Seattle, WAIt seems only natural that a patient assumes when a device is implanted in him—especially when that device is intended to be life-saving—that the device itself is free from defects. But according to a decades-old report by The New York Times (3/21/92), some Bjork Shiley heart valves may have been cracked and improperly sealed when they were implanted, putting some recipients of the Bjork Shiley valves at risk for serious complications, and even death.
The Times article reports that as of 1992, approximately 500 of the valves implanted worldwide had failed. Not a high number compared to the number that were implanted, but of the 500 failures, two-thirds of the patients died. That means that having the valve fail put patients at a greatly increased risk of death. Approximately 25,000 of the devices were implanted by 1986, when the FDA issued its recall.
The valves were recalled after concerns about the failure rate and the risk of death when the valves failed. According to the Times article, some Bjork Shiley valves were cracked before they were ever implanted, and those valves may not have been properly fixed. The article alleges that rather than properly welding cracked valves, the valves were simply polished over, and paperwork was forged to make it appear the valves had been properly repaired. Employee 2832, the employee who was said to have re-welded the valves, reportedly did not exist.
In 1992, Pfizer, maker of the Bjork Shiley valves, agreed to settle lawsuits filed by patients and loved ones affected by defective valves. The settlement, reported by The New York Times (1/25/92), was expected to cost between $155 and $205 million. In 1994, Pfizer agreed to pay $10.75 million to settle allegations from the Justice Department that the company lied when it applied for approval of the mechanical heart valve. The Justice Department had alleged that the device maker withheld evidence about the heart valve's failure potential and further made questionable statements about the medical value of the device.
Even decades after the settlements were announced, the FDA still looks to the Bjork Shiley ordeal. In a presentation on percutaneous aortic valves and drug eluting stents, Dr. Steven Greer noted, "The Bjork-Shiley fiasco taught us that a failed heart valve leads to rapid death."
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